FDA to Ban Sales of Dietary Supplements Containing Ephedra

2004 ◽  
Vol 32 (1) ◽  
pp. 184-186
Author(s):  
Amy G. Ling
Keyword(s):  
Weight Loss ◽  
Dietary Supplements ◽  
Dietary Supplement ◽  
Athletic Performance ◽  
Scientific Evidence ◽  
Federal Food ◽  
Education Act

On December 30, 2003, the FDA announced that it will publish a rule banning sales of ephedra - a dietary supplement often utilized for weight loss, increased energy, and enhanced athletic performance - because it poses an unreasonable health risk.The ban will be issued under the auspices of the Federal Food, Drug, and Cosmetic Act and the Dietary Supplement Health and Education Act of 1994 (DSHEA), in response to a process that began in June of 1997, when the FDA first proposed a mandatory warning statement on dietary supplements containing ephedra. FDAs analysis of the scientific evidence has led it to conclude that dietary supplements containing ephedrine alkaloids present an unreasonable risk of illness or injury and are therefore adulterated under Section 402(f)(1)(A) of the Federal Food, Drug, and Cosmetic Act?

FDA Statutory Authority to Regulate the Safety of Dietary Supplements

2005 ◽  
Vol 31 (2-3) ◽  
pp. 155-174 ◽  
Author(s):  
Peter Barton Hutt
Keyword(s):  
Dietary Supplements ◽  
Dietary Supplement ◽  
Food Additives ◽  
Food Additive ◽  
Food Ingredient ◽  
Safety Requirements ◽  
Statutory Authority ◽  
Federal Food ◽  
Color Additive ◽  
Education Act

For almost a century, the Food and Drug Administration (FDA) has regulated nutrients and other dietary supplement ingredients and products under the food provisions initially of the Federal Food and Drugs Act of 1906 and now of the Federal Food, Drug and Cosmetic Act of 1938 (“FD&C Act”), as amended. Congress amended the FD&C Act through the Food Additives Amendment of 1958 and the Color Additive Amendments of 1960 to strengthen FDA authority over food ingredient safety. In 1976, Congress enacted the Vitamin-Mineral Amendments which provides that FDA may limit the contents of dietary supplements only for safety reasons. In 1994, Congress enacted the Dietary Supplement Health and Education Act (“DSHEA”) to continue the regulation of dietary supplements under the food provisions of the FD&C Act but to replace the food additive provisions with separate safety requirements for dietary supplements and dietary ingredients.

scholarly journals Dietary supplements in the USA: problematic trends

2021 ◽  
pp. 1-5
Author(s):  
Bryan E Denham
Keyword(s):  
Weight Loss ◽  
Erectile Dysfunction ◽  
Dietary Supplements ◽  
Dietary Supplement ◽  
Prescription Drugs ◽  
Anabolic Steroids ◽  
Federal Courts ◽  
Safety And Efficacy ◽  
The Usa ◽  
Education Act

Abstract More than 25 years have passed since the Dietary Supplement Health and Education Act of 1994 classified dietary supplements as a subcategory of food, thereby exempting manufacturers from providing premarket evidence of product safety and efficacy. In this commentary, I discuss problems in the supplement industry through an examination of cases introduced or decided in US federal courts between 2010 and 2019. More than half the cases located involved defendants charged with introducing misbranded food or drugs into interstate commerce. Contaminants included anabolic steroids, erectile dysfunction medications, weight-loss drugs, workout stimulants and mind-altering substances. As the article points out, raw powders obtained in bulk quantities facilitate the practice of ‘home brewing’ and the introduction of prescription drugs into dietary supplements.

The New Dietary Ingredient Safety Provision of DSHEA: A Return to Congressional Intent

2005 ◽  
Vol 31 (2-3) ◽  
pp. 285-304 ◽  
Author(s):  
Scott Bass ◽  
Emily Marden
Keyword(s):  
Dietary Supplements ◽  
Dietary Supplement ◽  
Drug Administration ◽  
Consumer Demand ◽  
Food And Drug Administration ◽  
Safety Standards ◽  
Education Act ◽  
Definition Of ◽  
Preventative Healthcare

In the ten years since the passage of the Dietary Supplement Health and Education Act of 1994 (“DSHEA”), dietary supplements have become a widely available and important element of individualized preventative healthcare. Congress created DSHEA in response to great consumer demand, thereby embracing the dietary supplement category and opening the door for the growth of the dietary supplement industry. DSHEA introduced an expansive definition of dietary supplements and laid out available claims and strict safety standards for such products.While the statute has remained unchanged since its passage in 1994, the Food and Drug Administration (“FDA”) appears to be in the process of re-interpreting sections of DSHEA in ways that could fundamentally limit the availability of dietary supplements. Specifically, FDA has been utilizing DSHEA's “new dietary ingredient” (“NDI”) safety provision to narrow the scope of ingredients that can be considered, even before addressing their safety, for use in dietary supplements.

Why Consumers Need More Protection Against Claims for Dietary Supplements and Herbs

2003 ◽  
Vol 22 (5) ◽  
pp. 391-392 ◽  
Author(s):  
Stephen Barrett
Keyword(s):  
Dietary Supplements ◽  
Dietary Supplement ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Federal Agencies ◽  
Health Food ◽  
Enormous Amount ◽  
Education Act

Federal agencies have never had enough resources to cope with the enormous amount of deception in the supplement and health-food marketplace. Passage of the 1994 Dietary Supplement Health and Education Act (DSHEA) has worsened the situation by encouraging dubious claims and weakening the Food and Drug Administration (FDA)'s ability to ban dangerous products.

scholarly journals What is the research base for the use of dietary supplements?

1999 ◽  
Vol 2 (1) ◽  
pp. 35-38 ◽  
Author(s):  
Malden C Nesheim
Keyword(s):  
Dietary Supplements ◽  
Dietary Supplement ◽  
Health Professionals ◽  
Nutrition Support ◽  
The Public ◽  
Us Congress ◽  
Public Health Professionals ◽  
The Us ◽  
The Usa ◽  
Education Act

AbstractThe market for dietary supplements in the USA was estimated as about 11.8 billion dollars in 1997 with a growth rate of 10–14 % projected in the next 3 years. Data from the Food and Drug Administration collected in 1995 indicate that over 55 % of adults surveyed used some type of dietary supplement. The marketing of dietary supplements in the USA has been essentially deregulated by the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA). This legislation defined dietary supplements, made manufacturers responsible for the safety of supplements and allowed certain statements of nutrition support to be made on supplement labels. The US Congress in passing the DSHEA indicated that supplements should be available on the market so that consumers could make decisions about their use for themselves and their families. Unfortunately, information about the research base for supplement claims is not readily accessible to health professionals and consumers. There is a need for authoritative reviews of the data underlying supplement claims to assist public health professionals in their role of providing advice to the public about dietary supplements.

Truth and Consequences: The Perils of Half-Truths and Unsubstantiated Health Claims for Dietary Supplements

2000 ◽  
Vol 19 (1) ◽  
pp. 132-138 ◽  
Author(s):  
David C. Vladeck
Keyword(s):  
Dietary Supplements ◽  
First Amendment ◽  
Scientific Evidence ◽  
Health Claims ◽  
Nutrition Labeling ◽  
The Public ◽  
Commercial Speech ◽  
Court Of Appeals ◽  
Fda Approval ◽  
Education Act

The author examines the recent decision of the U.S. Court of Appeals in Pearson v. Shalala , which struck down on First Amendment grounds the Food and Drug Administration's (FDA's) regulatory scheme for approving health claims for dietary supplements. In its recent ruling, the Pearson court rejected the FDA's view that health claims that cannot be proved as either true or false pose a serious risk to consumers. Although the court recognized that some health claims will mislead consumers, it reasoned that the FDA's regulations are nonetheless impermissibly restrictive because they do not allow manufacturers to make health claims accompanied by clarifying disclosures when significant scientific agreement is lacking. The court suggested that disclaimers referring to the absence of FDA approval, or the inconclusive nature of the scientific evidence, might be sufficient to guard against consumer deception. The author explains why the reasoning of Pearson misconceives basic First Amendment commercial speech principles and places the public at risk. Congress enacted the Nutrition Labeling and Education Act to ensure that consumers would no longer be subjected to unreliable and unverifiable health claims for dietary supplements. Pearson thwarts that purpose. The disclaimers envisioned by the court will simply underscore the uncertainty about the product's utility. Accordingly, Pearson relegates consumers to a marketplace that will be rife with unproven and unreliable health claims and thus poses a real threat to the health of consumers.

The Dietary Supplement and Health Education Act and Supplements: Dietary and Nutritional Supplements Need No More Regulations

2003 ◽  
Vol 22 (5) ◽  
pp. 387-390 ◽  
Author(s):  
Bernd Wollschlaeger
Keyword(s):  
Health Education ◽  
Dietary Supplements ◽  
Dietary Supplement ◽  
Drug Administration ◽  
Federal Trade Commission ◽  
Food And Drug Administration ◽  
Nutritional Supplements ◽  
Consumer Access ◽  
Education Act ◽  
Enforcement Authority

The Dietary Supplement and Health Education Act (DSHEA) of 1994 was intended to ensure consumer access to safe dietary supplements, e.g., herbs, minerals, and vitamins. It granted the Food and Drug Administration (FDA) considerable enforcement authority to regulate dietary supplement industry. This article discusses relevant components of the DSHEA, explains the division of regulatory responsibilities between the FDA and the Federal Trade Commission (FTC), and refutes the often cited allegation that the herb and dietary supplement industry are unregulated.

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